Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Endometriosis Clinical Trial

Official title:

A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00556075
• Other study ID #: ZPE-201
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2007
• Last updated: August 8, 2014
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Premenopausal women aged 18-48 inclusive

• Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years

• Clinical symptoms of endometriosis for at least the past three (3) months

• Endometriosis symptoms

• Must be sexually active unless sexually inactive for endometriosis-related dyspareunia

• Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)

• Other inclusion criteria may apply

Exclusion Criteria:

• Six (6) months or more without a menstrual period, or

• Prior hysterectomy or

• Prior bilateral oophorectomy

• Diagnosis of osteopenia

• Present history or condition that causes non-endometriosis-related dyspareunia

• Presence of excessive bleeding or menorrhagia

• Abnormal screening endometrial biopsy

• Other exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Proellex 25 mg
1 capsule daily for 4 months
• Placebo
1 capsule daily for 4 months
• Proellex 50 mg
2 capsules daily for 4 months

Locations

Country	Name	City	State
United States	Physicians for Women	Cary	North Carolina
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	SC Clinical Research Center, LLC	Columbia	South Carolina
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Medical Associates	Dubuque	Iowa
United States	Gaffney Pharmaceutical Research	Gaffney	South Carolina
United States	Greenville Pharma Research	Greenville	South Carolina
United States	Altus Research	Lake Worth	Florida
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	HWC Women's Research Center	Miamisburg	Ohio
United States	Wake Research Associates	Raleigh	North Carolina
United States	Clinical Trials of Texas/Institute for Women's Health	San Antonio	Texas
United States	Clinical Trials of Texas/Seven Oaks Women's Center	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Compass Clinical Research	San Ramon	California
United States	Advanced Clinical Therapeutics, LLC	Tucson	Arizona
United States	Comprehensive Clinical Trials	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score		4 months	No
Primary	Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score		4 months	No
Secondary	Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits		monthly	No
Secondary	Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries		days	No
Secondary	Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries		days	No
Secondary	The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits		days	No